MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR INC.) OVATION IX; ILIAC LIMB

Model Number	TV-IL1422100-J
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Endologix will continue to investigate the reported event.The patient medical records and imaging studies have been requested for further evaluation by a clinical specialist.A final report will be submitted once the investigation of the reported event has concluded.
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm (aaa).Approximately 2 (two) years post-op the a type ib endoleak was identified on ct.Successful re-intervention was completed the same day by coiling the left hypogastric artery and extending the ovation ix limb with an unknown (non-endologix) 10x140mm stent graft.The leak was resolved.The patient was reported to be doing well.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported type ib endoleak was confirmed.Device, user, procedure or anatomy relatedness of this event could not be determined.The final patient status was discharged on the first post-operative day home stable.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device remains implanted; therefore, no device evaluation was completed.No additional investigation of this reported event is planned; however, if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Corrections: h6: result code ¿ remove 3233.H6: conclusion code ¿ remove 11.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 8593452
• Report Number: 3008011247-2019-00077
• Device Sequence Number: 11262168
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1422100J1
• UDI-Public: +M701TVIL1422100J1/$$3200403FS02071752A
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2020
• Device Model Number: TV-IL1422100-J
• Device Catalogue Number: TV-IL1422100-J
• Device Lot Number: FS020717-52
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OVATION IX MAIN BODY (LN FS052617-06); OVATION PRIME ILIAC LIMB (LN FS050917-11)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR